Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

FDA Recall Z-0655-2020 · Posted None

Recalling FirmCP Medical Inc
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2019-10-18
Product Quantity174 boxes 12 per box (plus 36 samples) - total of 2124 sutures

Reason for Recall

Failed to meet USP minimum average value for knot pull (tensile) strength.

Firm Action

Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.

Root Cause

Under Investigation by firm

Distribution Pattern

USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002190POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)Cp Medical · 2000-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑